(121 days)
The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradial in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.
Not Found
This is a difficult request to fulfill accurately. The provided text is a 510(k) clearance letter from the FDA for a medical device (Chiron Diagnostics ACS:180 Estradiol-6 II Assay). While it mentions that the device is "substantially equivalent" to previously marketed devices and permits marketing, it does not contain the detailed study information, acceptance criteria, or performance data that would be typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.
The document primarily focuses on the regulatory clearance process and confirms that the device can be marketed. It does not provide the specifics of the underlying studies that demonstrated performance or met acceptance criteria.
Therefore, I cannot extract the requested information directly from the provided text. To answer your questions, I would need a different type of document, such as:
- A Clinical Study Report (CSR)
- A Summary of Safety and Effectiveness Data (SSED), often found in FDA device approvals (though less common for a 510(k) without major new technology).
- A detailed 510(k) submission summary that includes performance data.
Based on the provided text, I can only state that:
- Acceptance criteria and reported device performance: Not explicitly stated in terms of quantitative values or specific assays. The letter only broadly implies that performance was deemed "substantially equivalent" to predicate devices.
- Sample size, data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned. This device is an immunoassay, so an MRMC study is highly unlikely to be relevant.
- Standalone performance study: The nature of this immunoassay suggests it would primarily be evaluated in a "standalone" fashion (i.e., algorithm/device only, producing a quantitative result). However, the specific details of such a study are not provided.
- Type of ground truth: For an immunoassay, the "ground truth" would typically be established through highly accurate reference methods or other well-validated laboratory methods. This is not detailed in the provided text.
- Sample size for training set: Not mentioned. This device is a pre-AI era immunoassay; the concept of a "training set" in the modern AI sense is not applicable.
- How ground truth for training set was established: Not applicable in the AI sense.
In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical and clinical study information required to answer your questions.
§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.